Transforaminal Lumbar Interbody Fusion (TLIF) (NCT04073563)
🩺 Plain-English Summary (8th-Grade Level)
This is a global, multi-center, prospective, randomized, blinded, controlled pivotal study. Clinical and radiological evaluation will be performed preoperatively and postoperatively up to 24 months; and endpoint success will be determined at 24 months postoperatively. Overall a maximum of 600 subjects will be enrolled and treated. The purpose of the study is to provide safety and effectiveness data of Infuse™ in Transforaminal Lumbar Interbody Fusion (TLIF) procedures and to obtain indication expansion for Infuse™ use in one and two level TLIF procedures.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (15 items) and avoid the listed exclusions (26 items).
Location: Mayo Clinic — Phoenix, Arizona
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria: A subject will be excluded from participating in this study for any of the following reasons:
- E.1 Prior surgical procedure at the involved or adjacent spinal levels (e.g. fusion, arthroplasty, and/or other non-fusion procedures). Prior discectomy and/or laminectomy at the target or adjacent levels is allowed.
- E.2 Significant lumbar instability defined as sagittal listhesis greater than Grade 2 at any involved level using the Meyerding Classification or lateral listhesis greater than 3 mm at any involved level.
- E.3 Planned use of an internal or external bone growth stimulator.
- E.4 Lumbar scoliosis \>30 degrees.
- E.5 Patients who had a previous diagnosis of osteoporosis with a T-score of -2.5 or below in the last 12 months existing together with a prevalent fragility fracture. (If subject has a prevalent fragility fracture and a T-score hasn't been assessed in the last 12 months, a DEXA will need to be obtained.)
- E.6 Morbidly obese, as defined by a Body Mass Index (BMI) \>40.
- E.7 Presence of active malignancy or prior history of malignancy (non-invasive basal cell carcinoma of the skin and non-invasive squamous cell carcinoma localized only to the skin is allowed).
- E.8 Overt or active bacterial infection, either local to surgical space or systemic.
- E.9 Has undergone administration of any type of corticosteroid, antineoplastic, immunostimulating, or immunosuppressive agents, or medications known to inhibit the healing of bone or soft tissue within 30 days prior to implantation of the assigned treatment.
- This includes patients ≥ 65 years of age taking warfarin with documented diagnosed osteoporosis. All other patients taking warfarin should washout for at least 5 days prior to treatment
- Use of steroidal inhalers is allowed pre- and post-operatively
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (46 Sites)
- Mayo Clinic — Phoenix, Arizona
- University of Arizona — Tucson, Arizona
- University of California Irvine — Irvine, California
- Memorial Health Services — Laguna Hills, California
- Cedars Sinai Spine Center — Los Angeles, California
- University of California Davis Medical Center — Sacramento, California
- University of Colorado Anschutz Medical Campus — Aurora, Colorado
- Boulder Neurosurgical Associates and Justin Parker Neurological Institute/E. Lee Nelson — Boulder, Colorado
- Vail-Summit Orthopaedics and Neurosurgery — Vail, Colorado
- Hartford Hospital — Hartford, Connecticut
- Advent Health Altamonte Springs — Altamonte Springs, Florida
- Mayo Clinic — Jacksonville, Florida
- Advent Health Orlando — Orlando, Florida
- Orlando Health — Orlando, Florida
- Foundation for Orthopaedic Research and Education — Tampa, Florida
- Rush University Medical Center — Chicago, Illinois
- Goodman Campbell Brain and Spine — Carmel, Indiana
- Indiana Spine Group — Carmel, Indiana
- OrthoIndy Northwest Office — Indianapolis, Indiana
- University of Iowa Hospitals and Clinic — Iowa City, Iowa
- Lahey Hospital & Medical Center — Burlington, Massachusetts
- Baystate Medical Center — Springfield, Massachusetts
- University of Michigan Health System — Ann Arbor, Michigan
- William Beaumont Hospital — Royal Oak, Michigan
- Mayo Clinic — Rochester, Minnesota
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.